Lundbeck and Otsuka’s brexpiprazole shows efficacy in Phase III trial

24 January 2014

Danish CNS drug specialist Lundbeck (LUND: CO) and Japanese drug maker Otsuka (TYO: 4768) have revealed positive top-line Phase III trial data on the investigational compound brexpiprazole.

Data from a Phase III, randomized, placebo-controlled study investigating the effect of brexpiprazole as adjunctive therapy to antidepressant therapy in patients with major depressive disorder (MDD) showed that brexpiprazole demonstrated efficacy and was well tolerated as adjunctive treatment for MDD patients with an inadequate response to antidepressant treatment. The results will be presented at the 22nd European Psychiatry Association Congress (EPA) in Munich, Germany on March 2. Highlighted data on brexpiprazole as adjunctive therapy to anti-depressant therapy in MDD will include:

Statistically significant improvements in mean MADRS total score for patients receiving adjunctive brexpiprazole compared with placebo. MADRS (Montgomery - Åsberg Depression Rating Scale) is a commonly used scale to assess the range of symptoms in patients with major depression;
A statistically significant advantage over placebo on all secondary endpoints;
Most common (>5% and more than twice placebo) adverse events reported in the patients receiving adjunctive brexpiprazole included weight gain and akathisia (inner restlessness)
Over 90% of patients completed the randomized phase of the trial; and
Additional information provided in the poster presentation at the EPA congress will be publicly disclosed at that time.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK